What are the responsibilities and job description for the Public Notice for Direct Hire (STEM) - Laboratory Quality Management Specialist position at HHS Careers?
Summary
As a global leader in public health & health promotion, CDC is the agency Americans trust with their lives. In addition to our everyday work, each CDC employee has a role in supporting public health emergency management, whether through temporary assignments to emergency responses or sustaining other CDC programs and activities while colleagues respond. Join our team to use your talent, training, & passion to help CDC continue as the world's premier public health organization. Visit www.cdc.gov
Learn more about this agency
Duties
The CDC utilizes Direct/Expedited Hire Authorities to fill vacancies in a variety of occupations. This vacancy is a REPOSITORY of applications. Duties and responsibilities vary and may increase according to the grade level of the position. Applications may be periodically referred to hiring managers both during the open period and after the closing date. Because of the large number of applications anticipated, applicants' status will not be updated.
This public notice will be used to fill the positions listed below at multiple grade levels and locations.
Duties May Include But Are Not Limited To:
Conditions of Employment
Due To The Centers For Disease Control And Prevention's (CDC's) Process Enhancement To Use Shared Certificates Throughout The Agency, Some Of The Requirements Below May Differ:
Basic Qualifications:
To qualify at the GS-11 grade level, you must have at least one year of specialized experience at or equivalent to the GS-09 grade level, which must include the following experience: performing quality reviews and measurement of laboratory functions involved in environmental response, biological testing of human and animal specimens, and pharmacology or other related science research applications or activities.
OR have completed 3 years of progressively higher level graduate education leading to a Ph.D degree or Ph.D. or equivalent doctoral degree in a field which demonstrates the knowledge, skills, and abilities necessary to perform the work of the position, such as biological sciences, agriculture, natural resource management, chemistry or related disciplines appropriate to the position.
OR have a combination of education and specialized experience that together meets 100% of the qualification requirement for this position.
To qualify at the GS-12 grade level, you must have at least one year of specialized experience at or equivalent to the GS-11 grade level, which must include the following experience: conducting clinical laboratory quality reviews to ensure compliance with clinical laboratory quality management systems, regulatory guidelines, policies, standards, processes and practices.
To qualify at the GS-13 grade level, you must have at least one year of specialized experience at or equivalent to the GS-12 grade level, which must include the following experience: performing laboratory quality management reviews; planning, developing and implementing laboratory quality control standards and practices; and making recommendations for compliance in reporting findings.
To qualify at the GS-14 grade level, you must have at least one year of specialized experience at or equivalent to the GS-13 grade level, which must include the following experience: in the development of and enhancement of Clinical Laboratory Improvement Amendments (CLIA) compliant laboratory testing systems; validating tests to meet CLIA requirements; and in the implementation of laboratory quality management systems in research and non-research laboratories.
Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
Promotion potential: Promotion to the next grade level is at management's discretion and is based on your meeting qualifications and time-in-grade requirements, demonstrated ability to perform the higher-level duties, the continuing need for the higher-level duties, and administrative approval. Promotion to the next grade level is not guaranteed and no promise of promotion is implied.
Education
A copy of your transcripts or equivalent documentation is required for positions with an education requirement, or if you are qualifying based on education or a combination of education and experience. An official transcript will be required if you are selected.
A college or university degree generally must be from an accredited (or pre-accredited) college or university recognized by the U.S. Department of Education. For a list of schools which meet these criteria, please refer to Department of Education Accreditation page .
FOREIGN EDUCATION: Education completed in foreign colleges or universities may be used to meet the requirements. You must show proof the education credentials have been deemed to be at least equivalent to that gained in conventional U.S. education program. It is your responsibility to provide such evidence when applying. For more information, visit https://sites.ed.gov/international/recognition-of-foreign-qualifications/ .
Additional Information
Telework: This position has been designated as telework eligible and:
Applicant Expiration: Applications will expire 4 months after submission/resubmission. To remain eligible for consideration, reapplying is required.
The Federal government, as the largest employer in the Nation, can and should show the way towards achieving drug-free workplaces through programs designed to offer drug users a helping hand, and at the same time demonstrating to drug users and potential drug users that drugs will not be tolerated in the Federal workplace if declared a drug-testing position. The use of illegal drugs, on or off duty, by Federal employees is inconsistent not only with the law-abiding behavior expected of all citizens, but also with the special trust placed in such employees as servants of the public.
Incentives:
Review our benefits
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
The utilization of shared certificates for additional selections within the same geographical area can be made from multiple Centers of the Center of Disease Control and Prevention (CDC) and Agency for Toxic Substance and Disease Registry (ATSDR).
This position is being filled through Direct Hire Authority for this occupation and is open to all US Citizens. Vacancies will be filled through OPM's Direct Hire Authority. Veterans' preference and traditional rating and ranking of applicants do not apply to positions filled under this announcement. All applicants who meet the minimum qualification requirements will be forwarded to the selecting official for consideration. Applications received as a result of job fairs, recruitment events, and emergency hiring mechanisms in support of this hiring initiative will also be accepted during the duration of the direct-hire authority.
For more information on OPM's authorization of Direct Hire Authority, please visit: https://www.opm.gov/policy-data-oversight/hiring-information/direct-hire-authority/
Once the application process is complete, a review of the resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP): CTAP/ICTAP eligibles must meet all of the requirements outlined in the qualification section of this announcement in order to be considered "well qualified."
As a global leader in public health & health promotion, CDC is the agency Americans trust with their lives. In addition to our everyday work, each CDC employee has a role in supporting public health emergency management, whether through temporary assignments to emergency responses or sustaining other CDC programs and activities while colleagues respond. Join our team to use your talent, training, & passion to help CDC continue as the world's premier public health organization. Visit www.cdc.gov
Learn more about this agency
Duties
The CDC utilizes Direct/Expedited Hire Authorities to fill vacancies in a variety of occupations. This vacancy is a REPOSITORY of applications. Duties and responsibilities vary and may increase according to the grade level of the position. Applications may be periodically referred to hiring managers both during the open period and after the closing date. Because of the large number of applications anticipated, applicants' status will not be updated.
This public notice will be used to fill the positions listed below at multiple grade levels and locations.
- Laboratory Quality Management Specialist: Grades GS-11 through GS-14
Duties May Include But Are Not Limited To:
- Assure implementation and maintenance of quality management system/essentials program and plan; and adherence to applicable guidelines and regulations, such as Clinical Laboratory Improvement Amendments (CLIA), Clinical and Laboratory Standards Institute (CLSI), Food and Drug Administration (FDA), and other national and international standards/accreditations.
- Ensure laboratory quality management requirements such as, standard operating procedures and protocols are in place, maintained, and meet appropriate regulatory requirements.
- Conduct periodic internal and external quality audits to include assessment of laboratory data, documenting regulatory compliance and identifying/reporting deficiencies.
- Advise management regarding nonconformities; recommend appropriate investigative, remedial and corrective action.
- Comply with all applicable federal and state safety and health regulations and established agency/organizational safety policies.
- Maintain required certifications and professional expertise in a science field/research quality control or assurance clinical laboratory standards, guidelines, and regulations.
Conditions of Employment
Due To The Centers For Disease Control And Prevention's (CDC's) Process Enhancement To Use Shared Certificates Throughout The Agency, Some Of The Requirements Below May Differ:
- US Citizenship is required.
- Males born after December 31, 1959 must be registered or exempt from Selective Service ( http://www.sss.gov ).
- May be subject to a Background/Security Investigation. Security clearance level may differ from the position announced when certificates are shared.
- CDC participates in the USCIS Electronic Employment Eligibility Verification Program ( E-Verify ). If selected, CDC will determine your employment eligibility using your social security number.
- Direct deposit is required.
- One-year probationary period may be required.
- This position may be subject to a Collective Bargaining Agreement.
- This public notice may be used to fill managerial positions with 20% supervisory duties. Applicants should describe any previous experience or responsibilities which could be used in relation to supervisory duties that demonstrate or show the potential to develop the necessary knowledge, skills, and abilities.
- Positions may be filled as permanent or term appointments.
- This position may be subject to the OGE Financial Disclosure requirements of the Ethics in Government Act of 1978 (P.L. 95-521). CDC inspires public confidence in its trust responsibilities and mission by maintaining high ethical principles. If selected, you may be required to complete a Confidential Financial Disclosure Report (OGE Form 450) to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. If identified, this will be an annual requirement.
- In accordance with Executive Order 12564 of September 15, 1986, The Department of Health and Human Services (HHS) is A Drug-Free Federal Workplace. This position may require a Drug Test and be subject to Random Drug Testing. The position may require the submission of a urinalysis to screen for illegal drug use prior to appointment and be subject to reasonable suspicion and post-accident drug testing upon hiring. If required to submit to urinalysis, the appointment to the position will be contingent upon a negative test result.
Basic Qualifications:
- Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
- Combination of education and experience: Courses equivalent to a major, as shown above, plus appropriate experience or additional education.
To qualify at the GS-11 grade level, you must have at least one year of specialized experience at or equivalent to the GS-09 grade level, which must include the following experience: performing quality reviews and measurement of laboratory functions involved in environmental response, biological testing of human and animal specimens, and pharmacology or other related science research applications or activities.
OR have completed 3 years of progressively higher level graduate education leading to a Ph.D degree or Ph.D. or equivalent doctoral degree in a field which demonstrates the knowledge, skills, and abilities necessary to perform the work of the position, such as biological sciences, agriculture, natural resource management, chemistry or related disciplines appropriate to the position.
OR have a combination of education and specialized experience that together meets 100% of the qualification requirement for this position.
To qualify at the GS-12 grade level, you must have at least one year of specialized experience at or equivalent to the GS-11 grade level, which must include the following experience: conducting clinical laboratory quality reviews to ensure compliance with clinical laboratory quality management systems, regulatory guidelines, policies, standards, processes and practices.
To qualify at the GS-13 grade level, you must have at least one year of specialized experience at or equivalent to the GS-12 grade level, which must include the following experience: performing laboratory quality management reviews; planning, developing and implementing laboratory quality control standards and practices; and making recommendations for compliance in reporting findings.
To qualify at the GS-14 grade level, you must have at least one year of specialized experience at or equivalent to the GS-13 grade level, which must include the following experience: in the development of and enhancement of Clinical Laboratory Improvement Amendments (CLIA) compliant laboratory testing systems; validating tests to meet CLIA requirements; and in the implementation of laboratory quality management systems in research and non-research laboratories.
Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
Promotion potential: Promotion to the next grade level is at management's discretion and is based on your meeting qualifications and time-in-grade requirements, demonstrated ability to perform the higher-level duties, the continuing need for the higher-level duties, and administrative approval. Promotion to the next grade level is not guaranteed and no promise of promotion is implied.
Education
A copy of your transcripts or equivalent documentation is required for positions with an education requirement, or if you are qualifying based on education or a combination of education and experience. An official transcript will be required if you are selected.
A college or university degree generally must be from an accredited (or pre-accredited) college or university recognized by the U.S. Department of Education. For a list of schools which meet these criteria, please refer to Department of Education Accreditation page .
FOREIGN EDUCATION: Education completed in foreign colleges or universities may be used to meet the requirements. You must show proof the education credentials have been deemed to be at least equivalent to that gained in conventional U.S. education program. It is your responsibility to provide such evidence when applying. For more information, visit https://sites.ed.gov/international/recognition-of-foreign-qualifications/ .
Additional Information
Telework: This position has been designated as telework eligible and:
- May include telework options and/or flexible work scheduling. These options may be requested once you have become an employee and you will be required to sign a Workplace Flexibilities Agreement that details remote or telework working conditions and expectations in accordance with the HHS Workplace Flexibilities Policy .
- May be eligible for inclusion in the Bargaining Unit.The name of the union, local, and BU Codes will be provided upon selection.
- For more information visit: https://www.usajobs.gov/Help/faq/job-announcement/telework/
Applicant Expiration: Applications will expire 4 months after submission/resubmission. To remain eligible for consideration, reapplying is required.
The Federal government, as the largest employer in the Nation, can and should show the way towards achieving drug-free workplaces through programs designed to offer drug users a helping hand, and at the same time demonstrating to drug users and potential drug users that drugs will not be tolerated in the Federal workplace if declared a drug-testing position. The use of illegal drugs, on or off duty, by Federal employees is inconsistent not only with the law-abiding behavior expected of all citizens, but also with the special trust placed in such employees as servants of the public.
Incentives:
- Recruitment and/or relocation incentives may be authorized.
- Annual Leave for non-federal service may be authorized.
- Student loan repayment incentive may be authorized.
- Travel, transportation, and moving expenses may be paid.
- PCS Expenses may be authorized, subject to the terms of the Joint Travel Regulation (JTR).
- Help
Review our benefits
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
The utilization of shared certificates for additional selections within the same geographical area can be made from multiple Centers of the Center of Disease Control and Prevention (CDC) and Agency for Toxic Substance and Disease Registry (ATSDR).
This position is being filled through Direct Hire Authority for this occupation and is open to all US Citizens. Vacancies will be filled through OPM's Direct Hire Authority. Veterans' preference and traditional rating and ranking of applicants do not apply to positions filled under this announcement. All applicants who meet the minimum qualification requirements will be forwarded to the selecting official for consideration. Applications received as a result of job fairs, recruitment events, and emergency hiring mechanisms in support of this hiring initiative will also be accepted during the duration of the direct-hire authority.
For more information on OPM's authorization of Direct Hire Authority, please visit: https://www.opm.gov/policy-data-oversight/hiring-information/direct-hire-authority/
Once the application process is complete, a review of the resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP): CTAP/ICTAP eligibles must meet all of the requirements outlined in the qualification section of this announcement in order to be considered "well qualified."
